Kristen PollockMcDonald

Partner

Atlanta + 1.404.581.8498

Kristen McDonald defends providers in False Claims Act litigation brought by federal and state agencies and qui tam whistleblowers. Her civil fraud experience involves billing, coding, medical necessity, kickbacks, eligibility, potential Stark liability, and documentation errors. Kristen defends providers in government extrapolated audits, and she also conducts internal investigations on behalf of providers and assists providers with repayments and self-disclosures. Additionally, she conducts internal investigations associated with HIPAA/HITECH concerns and defends providers in OCR investigations of potential breaches. She also defends providers in government enforcement actions involving civil money penalties and termination.

In addition, she has extensive experience conducting health care due diligence reviews for mergers, acquisitions, investments, and banking matters, focusing on fraud and abuse and other regulatory and compliance concerns. Kristen routinely advises providers and related investors on fraud and abuse analyses, telemedicine services and reimbursement, and compliance program development and effectiveness reviews, among other legal issues.

Kristen has represented hospitals/health systems; hospice, home health, skilled nursing facilities, and other post-acute care providers; pharmaceutical, medical device, and biologics manufacturers and distributors; telehealth companies; artificial intelligence companies; diagnostic imaging; ambulance suppliers; DMEPOS; financial institutions; and private equity investors.

Kristen is a member of the American Health Lawyers Association and serves as chair of AHLA's Health Care Liability and Litigation Practice Group.

Kristen has written and spoken extensively on health care issues, including risks and liabilities in telemedicine, meaningful use incentive payments and audits, ZPIC audits, government recoveries under the FCA, risk areas for post-acute care providers, and due diligence reviews.

Experience

  • Misonix merges with BioventusJones Day represented Misonix, Inc. (Nasdaq: MSON) in its acquisition by Bioventus Inc. (Nasdaq: BVS).
  • Bridge to Life announces first close of $56 million growth financingJones Day advised Bridge to Life, Ltd. in its $56 million capital raise consisting of a secured credit facility and a Series A preferred equity investment.
  • STERIS acquires Cantel Medical for $3.6 billionJones Day advised STERIS plc in its acquisition of Cantel Medical Corp, a global provider of infection prevention products and services primarily to endoscopy and dental customers, for $3.6 billion.
  • MedShape acquired by DJOJones Day advised MedShape, Inc., a privately held orthopedic medical device company founded in 2005, in connection with its acquisition by DJO, a subsidiary of Colfax Corporation.
  • MDLIVE sells company to Cigna's EvernorthJones Day advised MDLIVE in its sale to Cigna's health services subsidiary Evernorth.
  • Riverside portfolio company acquires PPM Advisory Group and OrtleyBioJones Day represented The Riverside Company in connection with the acquisition by portfolio company Red Nucleus of PPM Advisory Group and OrtleyBio, leading providers of scientific operations and communications services to global biopharmaceutical companies and brands, with a primary focus on oncology and hematology therapeutic areas.
  • PWNHealth and Home Access Health Corporation sold to Everlywell, forming Everly HealthJones Day advised PWNHealth LLC and Home Access Health Corporation in its sale to Everlywell, a leading digital health company, and forming Everly Health.
  • Sumitovant Biopharma acquires remaining stake in Urovant SciencesJones Day advised Sumitovant Biopharma in its acquisition of all of the outstanding shares of Urovant Sciences Ltd. not already owned by Sumitovant at a price of $16.25 per share in cash.
  • AbbVie acquires Mitokinin, Inc.Jones Day advised AbbVie Inc. in its exclusive right to acquire Mitokinin, Inc., a biotechnology company developing PINK1-targeted therapeutics for the treatment of neurodegenerative diseases, following completion of IND enabling studies on Mitokinin's lead PINK1 compound.
  • Digital health companies, specialty hospitals, and health systems maintain compliance with multistate requirements through 50-state surveyJones Day is representing digital health companies, specialty hospitals, and health systems in maintaining compliance with multistate requirements through a regularly updated, extensive 50-state survey on state laws and regulations applicable to telehealth activities of physicians and other health care professionals including licensing, establishing patient relationships, provider-to-provider consulting, supervision and delegation among providers, and prescribing and treatment standards.
  • Zyter acquires Casenet® LLCJones Day advised Zyter, Inc., a wholly owned subsidiary of Infinite Computer Solutions, Inc. and a leading digital health product company, in its acquisition of Casenet® LLC, a leading provider of population health products, from Cetene Corporation (NYSE: CNC).
  • Smith & Nephew acquires Extremity Orthopedics business of Integra LifeSciences Holdings Corporation for $240 millionJones Day advised Smith & Nephew plc, the global medical technology company, in its acquisition of the Extremity Orthopedics business of Integra LifeSciences Holdings Corporation (NASDAQ: IART) for $240 million on a cash and debt-free basis.
  • STERIS acquires Key Surgical for approximately $850 millionJones Day advised STERIS plc (NYSE: STE) in the $850 million acquisition of Key Surgical, a leading global provider of sterile processing, operating room, and endoscopy products, and a portfolio company of Water Street Healthcare Partners, LLC.
  • SOC Telemed merges with Healthcare Merger Corp.Jones Day provided healthcare and general corporate counsel to SOC Telemed, Inc. in its $720 million merger with Healthcare Merger Corp.
  • PolyOne acquires Clariant color and additive masterbatch business for $1.5 billionJones Day advised PolyOne Corporation in the $1.5 billion purchase of Clariant’s global color and additive masterbatch business.
  • National diagnostic clinician network expands telehealth programming in response to COVID-19 public health crisisJones Day represented a national diagnostic clinician network in their expansion of telehealth programming in response to the COVID-19 public health crisis.
  • National digital health company launches government partnershipJones Day advised a large digital health company with multi-clinical services in negotiating a partnership with a state government program to provide telehealth and telemedicine consults during the COVID-19 state of emergency.
  • Smith & Nephew acquires Tusker Medical, Inc.Jones Day advised Smith & Nephew plc, the global medical technology company, in the acquisition of Tusker Medical, Inc., the developer of the Tula System, an in-office solution for tympanostomy tubes (commonly known as ear tubes).
  • Leading financial services company provides $300 million credit facility for acquisition of oral healthcare and insurance companyJones Day represented a leading financial services company, as left lead arranger and administrative agent, in a $300 million senior secured syndicated revolving credit facility in connection with a private equity-backed acquisition of an oral healthcare and insurance company.
  • Sumitomo Dainippon Pharma acquires late stage biopharma companies and forms alliance with Roivant Sciences Ltd. worth $3 billionJones Day advised Sumitomo Dainippon Pharma Co., Ltd. ("Sumitomo") in an acquisition of late stage biopharma companies and formation of alliance with Roivant Sciences Ltd.
  • Additional Publications

    • October 20, 2015
      AseraCare Update: Jury Finds Majority of Sampled Claims False, AseraCare Seeks JMOL Following Phase One of Bifurcated Trial, American Health Lawyers Association Practice Group, Email Alert
    • August 28, 2015
      Fifth Circuit Requires Pharmacies to Arbitrate Claims Against Non-Signatories to Arbitration Agreement, American Health Lawyers Association Practice Group Email Alert
    • December 27, 2013
      Another Record Year for Government Recoveries under the False Claims Act, American Health Lawyers Association Practice Group, Email Alert
    • October 2013
      What Hospitals Need to Know About ZPIC Audits, Healthcare Financial Management Association
    • November 2012
      What do you do when a ZPIC comes knocking? Compliance Today, Health Care Compliance Association
    • August 29, 2012
      Beware of the Minefield - The New Survey and Enforcement Landscape for Home Health Agencies, The American Health Lawyers Association's Healthcare Liability and Litigation Health Briefs
    • February 1, 2012
      The Various Weapons in the ZPIC Arsenal, The American Health Lawyers Association's LTC-SIR Advisor
    • December 22, 2011
      Why the Anti-Kickback Statute May Be the Tip of the Iceberg When It Comes to Questionable Vendor Arrangements, The American Health Lawyers Association's LTC-SIR Advisor
    • May 2011
      Nursing Homes May Find Some Solace Amid the Storm of New Regulations Governing the Assessment of CMPs, American Health Lawyers Association's Healthcare Liability and Litigation Practice Group, May 2011 Health Briefs e-Newsletter
    • June 21, 2010
      Has a Trap Been Set? - What Risks Lie Ahead for Nursing Homes Compelled to Disclose Organizational Information under the Patient Protection and Affordable Care Act, American Health Lawyers Association's Healthcare Liability & Litigation Health Briefs
    • February 17, 2010
      New Guidance on the Indicia of Reliability Standard: What Now Faces Potential Relators in False Claims Act Litigation, American Health Lawyers Association's Healthcare Liability & Litigation Health Briefs

    Speaking Engagements

    • April 21, 2020
      Part 2: Opportunities and Risks for Telehealth under HIPAA and State Privacy Responses to the COVID-19 Pandemic,” American Telemedicine Association , COVID-19 Response Webinar Series
    • April 14, 2020
      Part 1: Opportunities and Risks for Telehealth under HIPAA and State Privacy Responses to the COVID-19 Pandemic,” American Telemedicine Association , COVID-19 Response Webinar Series
    • April 15, 2019
      The Evolving Landscape of Telehealth: Politics, Policy, Operations and Oversight, American Telemedicine Association
    • February 24, 2015
      Long Term Care and the Law: Why Long Term Care Providers are Finding New Uses for ADR: Best Practices for an Evolving Landscape, American Health Lawyers Association
    • February 19, 2015
      Due Diligence Reviews in Healthcare Transactions, Jones Day's CLE Academy
    • December 17, 2013
      Advocating Effectively in Health Care Arbitrations, American Health Lawyers Association
    • November 2011
      Beware of the ZPIC - Tips and Tactics from the Trenches, American Health Lawyers Association
    • Fall 2009
      Federal and state efforts to improve patient safety and reduce medical errors, Patient Safety and Never Events